- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01912404
Study of IDN-6556 in Patients With Severe Alcoholic Hepatitis and Contraindications to Steroid Therapy (AH)
September 16, 2016 updated by: Conatus Pharmaceuticals Inc.
A Placebo-Controlled, Multicenter, Double-Blind, Randomized Trial of IDN-6556 in Patients With Severe Alcoholic Hepatitis and Contraindications to Corticosteroid Therapy
The main purpose of the study is to test if taking a study drug called emricasan (also known as IDN-6556 and PF-03491390) will affect overall patient survival after one month of treatment.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
The study will also see if overall patient survival is affected at 6 months, and if the study drug improves liver function.
Study Type
Interventional
Enrollment (Actual)
5
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Indiana
-
Indianapolis, Indiana, United States, 46202
- Indiana University
-
-
Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic
-
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Virginia
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Richmond, Virginia, United States, 23298
- Virginia Commonwealth University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Able to provide written informed consent (either from patient or patient's legally acceptable representative), and understand and willing to comply with the requirements of the study
- Male or female patients 21 years of age or older
Patients with alcoholic hepatitis defined as:
- History of heavy alcohol abuse use: >40 g/day in females and >60 g/day in males for most days in a minimum period of 6 months
- Consumed alcohol within 6 weeks of entry into the study
- Biochemical parameters of severe disease as evidenced by MELD score >20 but <35, or MELD score 35-40 if the SOFA score is <10
- Willingness to utilize 2 reliable forms of contraception (for both males and females of childbearing potential) from screening to 1 month after the completion of study treatment
Patients with established contraindications to steroid use including but not limited to the following:
- GI bleed
- Active infection, including spontaneous bacterial peritonitis, based on positive blood culture, urine culture, or chest x-ray (if positive, must have been on antibiotics for at least 24 hours prior to study entry)
- Acute pancreatitis (increased lipase > 3x ULN or radiologic evidence)
- Positivity for hepatitis B (HBsAg+) or C virus (HCV+), and
- Renal failure
Exclusion Criteria:
Other or concomitant cause of liver disease as a result of:
- Autoimmune liver disease (positive anti-mitochondrial antibody and smooth muscle antibody, positive reading on anti-nuclear antibody titer >1:160)
- Metabolic liver disease (abnormal ceruloplasmin levels)
- Vascular liver disease
- Drug induced liver disease Note: Concurrent viral hepatitis is not excluded.
- Co-infection with human immunodeficiency virus (HIV)
- Sepsis as evidenced by positive blood or urine culture, or pneumonia as confirmed by x-ray
- History of renal transplant and/or on dialysis at time of entry into study
- Inflammatory bowel disease
- Diagnosed or suspected systemic lupus erythematosus (SLE) and/or rheumatoid arthritis (RA)
- Hepatocellular carcinoma (HCC) at entry into the study
- Active non-liver malignancies other than curatively treated skin cancer (basal cell or squamous cell carcinomas)
- Active tuberculosis on chest x-ray at study entry
- History or presence of clinically concerning cardiac arrhythmias, or prolongation of screening (pre-treatment) QT or QTc interval of >480 milliseconds (msec)
- Significant systemic or major illness other than liver disease, including coronary artery disease, cerebrovascular disease, pulmonary disease, renal failure, serious psychiatric disease, that, in the opinion of the Investigator would preclude the patient from participating in and completing the study
- Patients requiring the use of vasopressors or inotropic support
- Liver biopsy, if carried out, showing findings not compatible with alcoholic hepatitis
- Any patient that has received any investigational drug or device within 30 days of dosing or who is scheduled to receive another investigational drug or device in the course of the study Note: Investigational drug includes any drug that is used off-label.
- If female, known pregnancy, or has a positive urine or serum pregnancy test, or lactating/breastfeeding
- If male, if partner is known to be pregnant at time of entry into study or becomes pregnant while patient is on study drug or up to 1 month after completion of study drug
- Appropriate candidate for corticosteroid therapy
- Treatment for alcohol hepatitis within 1 month of study entry with use of corticosteroids for >1 week or corticosteroid use at the time of entry into the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: IDN-6556
IDN-6556 capsules, 25 mg BID
|
25 mg BID for 28 days
Other Names:
|
Placebo Comparator: Placebo
Placebo capsules BID
|
Placebo controlled
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Survival
Time Frame: 28 days
|
28 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: David Hagerty, MD, Conatus Pharmaceuticals
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2013
Primary Completion (Actual)
August 1, 2015
Study Completion (Actual)
August 1, 2015
Study Registration Dates
First Submitted
July 29, 2013
First Submitted That Met QC Criteria
July 29, 2013
First Posted (Estimate)
July 31, 2013
Study Record Updates
Last Update Posted (Estimate)
November 4, 2016
Last Update Submitted That Met QC Criteria
September 16, 2016
Last Verified
September 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Chemically-Induced Disorders
- Digestive System Diseases
- Alcohol-Related Disorders
- Substance-Related Disorders
- RNA Virus Infections
- Virus Diseases
- Infections
- Liver Diseases
- Hepatitis, Viral, Human
- Enterovirus Infections
- Picornaviridae Infections
- Liver Diseases, Alcoholic
- Alcohol-Induced Disorders
- Hepatitis
- Hepatitis A
- Hepatitis, Alcoholic
Other Study ID Numbers
- IDN-6556-04
- 5U01AA021788 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
Study was terminated early with insufficient subjects for meaningful analysis.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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